—#168294

Product

GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.

FDA product code: CBK — Ventilator, Continuous, Facility Use
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K142679
Affected lot / code info: a) 2066713-001 Lot Numbers: 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130 b) 2083208-001 Lot Numbers: 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130

Why it was recalled

The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.

Root cause (FDA determination)

Process control

Action the firm took

The firm, GE Healthcare, initiated an "URGENT MEDICAL DEVICE CORRECTION" on 10/05/2018 by letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Follow the safety instructions and If you have any incorrect ISGs, return to GE Healthcare or destroy on site, and complete and return the attached Customer Response form checking box #2 to indicate that you do have affected ISGs. E-mail the completed form to Recall34095.InspiratorySG@ge.com. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. The firm initiated a new recall notice identifying a new issue on 02/01/2019

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide Distribution: US (Nationwide) including Puerto Rico, and to countries of: Albania, Argentina, Australia, Austria, Bangladesh, Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Honduras, Hungary, India, Indonesia, Iraq, Italy, Japan, Kazakhstan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Malaysia, Maldives, Mexico, Myanmar, Nepal, Netherlands, Nicaragua, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.

Timeline

Recall initiated: 2018-10-05
Posted by FDA: 2018-11-30
Terminated: 2024-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168294. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.